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Author
Topic: Viramune XR - undigested? (Read 5883 times)

Hello,I've been on Viramune & Truvada for five years with excellent results. Last month, they switched me to Viramune XR. I don't know how to put this delicately, so here goes... lately I've noticed white stuff in my stool that I think is undigested tablets. And it's not of an insignificant size... more like chunks that look 1/2 to 3/4 the size of the original tablet. I did a Google search and found a very unofficial looking site that mentioned something about this happening (i.e. soft remnants in stool), but the amount I'm seeing makes me wonder how it could be insignificant. It really seems like a lot to pass through undigested! So now I'm kind of freaking out, thinking that maybe I'm not getting the full dose and wondering if this could lead to drug resistance. Has anybody noticed this happening who's taking Viramune XR? Anybody heard anything about this from their doctor?AJM

Perhaps take end of the road sample to your doc and see if s/he thinks it is the meds? If it is then you are possibly not getting enough Viramune. If it's something else then it may need investigation/treatment.

One more thing, Do you take your meds with a meal, or on an empty stomach ? You may want to try eating just before or after taking the Viramune. I always have something to eat, shortly after taking my medication.

XR is not yet available here (this due to bureaucratic red tape, which pisses me off, and hte fact that the manufactuer is trying to get rid of there inventory, I guess)

It is of upmost importance for your pill buddies that that you clarify this and get to the end of it ( ;-) )

One thing I will do when I get these new pills. (but who ever has some may want to try it): take a glass of water (slightly warm, to body temperature 37 deg C)drop a pill into itobserve what happensstirr gently (like you would do with coffee creamer or sugar)observe what happens.

Standard time of residence in stomach for a pill is 2 hours

You stomach is not a water environnment is a chloride acid with low pH. You may find chloride acid at the supermarket. It is not THAT dangerous, but latex gloves and eye protection is recommended, then try the same as the above

This would be some DIY test mimicking the many tests that the manufacturer must have performed before applying for FDA approval.

This is easy enough to perform and would shed some light on what is going on.

As soon as I get the pills I'll try...

Picking up a sample of your stool may sound well... hum... dirty. but you can

you can even clean the white part out and observe with binoculars.

Viramune (the standard) as a sugary taste, as it has lactose in it and is not coated

Thus, I could suggest another test (taste) , but you may not like the idea...

To clarify, I took the XR formulation for a couple of weeks and didn't notice this problem... at least not this bad (i.e. big chunks of tablet) I take my meds first thing in the morning on an empty stomach with about a pint of water.

What changed is that I started doing two things: (1) cross training at 5:30AM for an hour, then Bikram yoga (hot room yoga) at 9AM for 1.5 hours. I end up drinking a total of about 2 liters of water during and after. That's because you sweat like crazy in the yoga. (I eat breakfast in between the cross training and yoga.)(2) I got a juicer and started making daily veg juices out of the following: apple, carrot, beet, ginger, kale, pomegranate, celery, cabbage. Yes, it tastes awful but I like how it makes me feel - lots of energy! (I've been drinking about 2 pints of that stuff each day.

So, I'm wondering if too much fluids is diluting my digestive juices? Or maybe something in the juice is interfering with tablet breakdown?

It's so frustrating that I'm being 100% compliant in taking my meds, plus going the extra mile with exercise and diet... and now I have what looks like undigested meds in my poo!

So now I stopped the juicing and cut back on the yoga and will see what happens. If that fixes it, I'll reintroduce each, one at a time, to see what happens.

Jeez, so complicated. Why can't life just be simpler!

No I will not be trying the taste test. That's a little too DIY for me.

OK ajm_ldn, you're not alone. I clearly saw an undigested Viramune XR tablet in my poop today! This was about 8 hours after I took it. Did you get any answer from your pharmacist? I'm callign mine and my doc tomorrow, I will be supremely pissed off if I've developed some resistance from not having full bioavailability of the Viramune.

So here's the poop (so to speak) I got from the Pharmacy department. Viramune XR has been dispensed here for about two months. Since that time about five of us have reported not having it digest properly. I guess one of the benefits of "socialized medicine" and dispensing all HIV drugs out of one organization means they get feedback pretty quick. Boehringer says its the shell, but I poked the poop and seemed like more than a shell.

So I had my labs done, including one for the level of viramune in my blood after 24 hours and then asked them to switch me to the original two pill formulation.

A friend of mine had the same with the XR version; visible pill remnants in stool. He reported this immediately to his ID doc, who then ordered a bloodlevel test. Result: viramune bloodlevel was way too low, and he was put back on the previous 2 x 200mg regiment.Worth mentioning: despite too low bloodlevels, his VL dropped significantly from 800.000 to 750 while on the XR.

Well according to my docs, thanks to those of us who look at our poo, the HIV Centre has halted dispensing Viramune XR until they can get some answers from Boehringer about this issue. So everyone in BC will will be back on the original formulation until its cleared up. Surprised there hasn't been anything about XR in the "News" section of the website.

They didn't have the Viramune level test ready, but my other labs showed a drop in cd4 from 1010 to 650, but still undetectable and % increasing from 34 to 43. I did have a cold at the time of the draw, so maybe that explains the cd4 drop.

I hope it turns out well. I'd be interested to hear what the test results say.

Before taking Viramune XR, I was taking the old formulation (two pills) once a day without any problems. I heard that a lot of people did this without any problem before the XR came out. Maybe I'll go back to that just to be safe.

Logged

"The trouble with the world is that the stupid are cocksure and the intelligent are full of doubt."

After getting new path results and still stable, I'm thinking maybe this may be nothing to worry about. Thats my opinion only based on my Doc's reply, my labs, and the reply from Boehringer. I've recieved the following reply :

Thank you for your enquiry. I understand you have been observing undigested Viramune XR® tablet remnants in your faeces every day.

The inactive ingredients of Viramune XR extended-release tablets may occasionally be eliminated in the faeces as soft, hydrated remnants. This is a result of the extended release mechanism of the tablet. The inactive ingredients absorb moisture and form a matrix through which the active ingredient, nevirapine, is slowly released.

A number of patients taking Viramune XR in clinical trials noted tablet remnants in their faeces. Despite this finding all patients had the expected concentration of nevirapine in their blood and a sustained viral response.

I understand from your email that you have consulted your doctor and a recent blood test showed your CD4 counts remain stable. It would therefore appear that the tablet remnants you are noting in your faeces is not associated with any lack of drug effect.

Given the tablet mechanism, the clinical trial findings and your own blood test results it would appear that the undigested pills you are observing in your faeces is the inactive tablet ingredients.

I hope this email alleviates your concerns. A copy of the Consumer Medicine Information for Viramune XR is attached for your reference. If you have any further questions please do not hesitate to contact us.

it would appear that the undigested pills you are observing in your faeces is the inactive tablet ingredients.

That makes sense if you think of the "inactive tablet ingredients" as being a framework in which the active ingredients are lodged to achieve the time-release effect. You're just seeing the "empty" framework.

"...health will finally be seen not as a blessing to be wished for, but as a human right to be fought for." Kofi Annan

Nymphomaniac: a woman as obsessed with sex as an average man. Mignon McLaughlin

HIV is certainly character-building. It's made me see all of the shallow things we cling to, like ego and vanity. Of course, I'd rather have a few more T-cells and a little less character. Randy Shilts

Thanks for following up with the manufacturer. This is very helpful for me, as I'm about to start Viramune XR in a few weeks.

But after this 90 day supply of Viramune XR, I'm going to switch back to Virarmune, since it is now available in generic form -- and will save me a ton of money.

Cheers,

Henry

Logged

"Life in Lubbock, Texas, taught me two things: One is that God loves you and you're going to burn in hell. The other is that sex is the most awful, filthy thing on earth and you should save it for someone you love." - Butch Hancock, Musician, The Flatlanders

Apparently the manufacturer is aware of the issue and offers a rationale for it

Thus far I have never seen anything from the manufacturer that clearly addresses this issue (which they are apparently aware of) and, IMHO, this is a blunder in terms of communication and a lack of respect for their customers

Let'see what official bodies like Canadian health care or FDA have to say about this...

That makes sense if you think of the "inactive tablet ingredients" as being a framework in which the active ingredients are lodged to achieve the time-release effect. You're just seeing the "empty" framework.

Yes well said Ann...Makes sense to me, my Doc also reminded me the TGA would have ensured the effectiveness of any new or improved version of a currently approved drug, but hey, never hurts to question things... right?

Just glad it's been sorted, this combo has been great, absolutely zero side effects so I kind of wanted to get to the bottom of it, no pun intended.

After hearing from Boehringer, and talking to my own good Doctor, the stress is no longer...hope a few others here using XR or about to switch to XR can do so now without doubts.Cheers!

I forgot to post, the labs I had done before switching off XR and back to the original formula showed a high level of viramune in my system. So even though I was poopin' what looked like large chunks of the pill, it was being absorbed sufficiently.